Severe Acute Respiratory Syndrome (SARS) (also referred to as “atypical pneumonia”) brings about a severe threat to human life. The World Health Organization (WHO) recognizes that Severe Acute Respiratory Syndrome (SARS) is a disease caused by a variant of subtype of Coronavirus, i.e. SARS virus and exhibits clinically an inflammatory reaction. Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS) emerges when the disease worsens.
Ulinastatin is a glycoprotein isolated from human urine, and is also called human urine trypsin inhibitor (UTI). Ulinastatin is first marketed in Japan in 1985 and has been used as a medicament for the treatment of acute pancreatitis, acute circulatory failure and shock. Animal experiments have demonstrated that Ulinastatin possesses a variety of special pharmacological properties. For example, Ulinastatin may be used to improve immunologic function and protect visceral function. SHINYA MURAKAMI et al. reported that Ulinastatin not only inhibited various serine proteinase such as trypsin, α-chymotrypsin, fibrinolysin and multinuclear granulocyte elastase, but also inhibited the release of inflammation mediators from leukocyte such as TNF-α, IL-1 and IL-6 and the release of oxygen free radical (Tissue Culture Engineering, 2001, 27(9), p. 348-354). It is currently known that multinuclear granulocyte elastase, inflammation mediator and oxygen free radical are involved in the pathogenesis of Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS). The inventor of the application has conducted intensive clinical studies and found that Ulinastatin is highly effective for the treatment of Severe Acute Respiratory Syndrome (SARS), and particularly for the treatment of Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS) induced by SARS.